MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM

Computer, Diagnostic, Programmable

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES

The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Modification To: Mac-lab/cardiolab Ep/combolab System.

Pre-market Notification Details

Device IDK032577
510k NumberK032577
Device Name:MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
ClassificationComputer, Diagnostic, Programmable
Applicant GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee,  WI  53223
ContactLisa L Michels
CorrespondentLisa L Michels
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee,  WI  53223
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-21
Decision Date2003-10-10
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.